Ignite Creation Date:
2025-12-25 @ 5:10 AM
Ignite Modification Date:
2025-12-26 @ 4:15 AM
Study NCT ID:
NCT06697327
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-14
First Post:
2024-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Daunorubicin + Cytarabine + Venetoclax in de Novo AML
Sponsor:
Anhui Medical University
Organization:
Study Overview
Official Title:
Daunorubicin Plus Cytarabine 3+5 Regimen Combined With Venetoclax in de Novo Patients With Acute Myeloid Leukemia: a Single Center, Open-label, Controlled Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a non-profit, prospective, single-center, open-label, controlled clinical trial aimed at evaluating the efficacy of the daunorubicin, cytarabine, and venetoclax (DAV) regimen in previously untreated adult AML patients eligible for intensive chemotherapy.The combination of daunorubicin administered for 3 consecutive days and cytarabine for 7 consecutive days constitutes the classic "3+7" induction chemotherapy regimen for AML patients eligible for chemotherapy. The addition of venetoclax to the "3+7" regimen has shown promising efficacy in newly diagnosed AML patients suitable for intensive therapy. However, this approach is associated with increased adverse reactions. Based on current clinical studies, we propose a modified approach involving reduced-dose chemotherapy combined with venetoclax for AML treatment, aiming to achieve optimal efficacy while effectively reducing adverse reactions.
Detailed Description:
PRIMARY OBJECTIVE:
1\. To evaluate the efficacy of the regimen, as defined by complete remission (CR), complete remission with partial hematologic recovery (CRh), complete remission with incomplete hematologic recovery (CRi), morphological leukemia-free state (MLFS), and partial remission (PR).
SECONDARY OBJECTIVES:
1. To evaluate the long-term effectiveness and durability of the treatment of the regimen, as defined by 1-year overall survival (OS), 1-year event-free survival (EFS), and duration of remission (DOR).
2. To evaluate the safety of the regimen, as defined by Grade 3-4 clinical adverse events (AEs), incidence of laboratory abnormalities, and treatment-related mortality (TRM).
OUTLINE:
* The regimen for the control group includes:(Daunorubicin, Cytarabine)
* Daunorubicin: 60 mg/(m²·d) on days 1 to 3
* Cytarabine: 100 mg/(m²·d) on days 1 to 7
* The experimental group's "DAV" regimen includes: (Daunorubicin, Cytarabine, Venetoclax)
* Daunorubicin: 40 mg/(m²·d) on days 1 to 3
* Cytarabine: 100 mg/(m²·d) on days 1 to 5
* Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg from days 3 to 14
* The "DAV" regimen is designed to shorten the duration of induction chemotherapy while extending the application period of venetoclax, aiming to improve efficacy while reducing adverse effects.
1\. To evaluate the efficacy of the regimen, as defined by complete remission (CR), complete remission with partial hematologic recovery (CRh), complete remission with incomplete hematologic recovery (CRi), morphological leukemia-free state (MLFS), and partial remission (PR).
SECONDARY OBJECTIVES:
1. To evaluate the long-term effectiveness and durability of the treatment of the regimen, as defined by 1-year overall survival (OS), 1-year event-free survival (EFS), and duration of remission (DOR).
2. To evaluate the safety of the regimen, as defined by Grade 3-4 clinical adverse events (AEs), incidence of laboratory abnormalities, and treatment-related mortality (TRM).
OUTLINE:
* The regimen for the control group includes:(Daunorubicin, Cytarabine)
* Daunorubicin: 60 mg/(m²·d) on days 1 to 3
* Cytarabine: 100 mg/(m²·d) on days 1 to 7
* The experimental group's "DAV" regimen includes: (Daunorubicin, Cytarabine, Venetoclax)
* Daunorubicin: 40 mg/(m²·d) on days 1 to 3
* Cytarabine: 100 mg/(m²·d) on days 1 to 5
* Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg from days 3 to 14
* The "DAV" regimen is designed to shorten the duration of induction chemotherapy while extending the application period of venetoclax, aiming to improve efficacy while reducing adverse effects.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: